Dr Munshi on the Final Results of the CARTITUDE-1 Trial of Cilta-Cel in R/R Myeloma

Nikhil C. Munshi, MD, director of the Basic and Correlative Science at Jerome Lipper Multiple Myeloma Center; Kraft Family Chair, director of Multiple Myeloma Immune Effector Cell Therapy, senior physician at Dana-Farber Cancer Institute; and a professor of Medicine at Harvard Medical School, discusses the efficacy data from the final analysis of the phase 1b/2 CARTITUDE-1 trial (NCT03548207) of ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma.

Updated findings presented at the 2023 EHA Congress showed that patients experienced a median progression-free survival of 34.9 months (95% CI, 25.2-not estimable [NE]). The expected median PFS with the use of prior standard of care for this patient population typically ranged from 4 to 5 months, Munshi says. The 30-month PFS rate was 54.2%, and he notes that achieving a complete response and sustained minimal residual disease negativity were associated with prolonged PFS. The median duration of response was 33.9 months (95% CI, 25.5-NE)

Additionally, the median overall survival (OS) was not yet reached at the final analysis of CARTITUDE-1. An estimated 62.9% of patients were alive at 3 years of follow-up, which was another notable finding for a patient population with an expected median OS of 12 months, Munshi says. 

In February 2022, the FDA approved cilta-cel for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Previously reported data from CARTITUDE-1 supported the approval, demonstrating that cilta-cel elicited an overall response rate of 98% (95% CI, 92.7%-99.7%).

Munshi explains that the long-term data from the final analysis confirm the durability of responses for cilta-cel observed in this patient population. Given the efficacy displayed by cilta-cel in heavily pretreated patients who received a median of 6 prior lines of therapy, the CAR T-cell therapy represents a beneficial treatment option for patients with relapsed/refractory multiple myeloma, Munshi concludes.